The success rate to identify a multi-specific lead molecule with favorable drug-like properties increases with the number of variants tested. We report here the establishment of a novel, automated platform process for the fast generation of large panels of multi-specific variants (up to 10,000). Our high-throughput process integrates emerging cloning technologies with state-of-the-art automation and workflow supporting bioinformatics based on Genedata Biologics Database.

This presentation will showcase how Alexion has implemented streamlined processes across multiple sites to automate our engineering and production of enzyme replacement therapeutics (ERTs) as well as single and multi-domain antibodies. The selection of expression system for antibody therapeutics and ERTs will be discussed, and thorough comparison between Expi293 and ExpiCHO will be presented.

Kymab have developed an advanced technology to visualise and deeply explore the Kymouse™ antibody repertoire. We can identify candidate-quality molecules with exceptionally broad diversity and with the quality of fully human antibodies. Our platform allows rapid, detailed and efficient exploration of the B-cell response to immunisation as well as informing and supporting decision making process throughout our discovery program. We will present our work with the Bill and Melinda Gates foundation.

Development of an Automated Parallel System for Production of High-Quality Lead Candidate Antibodies – Keeping Pace with Researchers' Appetites Lars Linden, Ph.D., Head, Protein Biochemistry, Bayer HealthCare

In early research, project teams profile multiple antibody candidates in functional and often cell-based assays. Within a growing portfolio, this leads to an increasing resource need for the production of mg amounts of high-quality antibodies. To meet this demand, transient transfection and expression were automated, a novel high-throughput 2-step chromatography system was set up, and an integrated automation concept for sample handling was developed.

Global Biotherapeutic Technologies at Pfizer uses a number of biophysical and biochemical assays to predict the developability of early stage biotherapeutics. Data from these assays is used to remove sequence liabilities before they can cause problems in production. To improve access to this data and allow analysis across multiple projects, we have recently implemented a database to store these results and provided web applications to simplify its deposition and analysis.

From Spreadsheets to a Centralized End-to-End Biologics Repository and Analysis PlatformPeter Henstock, Ph.D., Senior Principal Scientist, Research Business Technologies, Pfizer

The challenge described was the alignment of workflows and centralization of data for 200+ Pfizer scientists in 15 groups located at 7 sites. After an aborted earlier attempt with a develop-as-you-go approach, we decided to implement an infrastructure as the backbone platform and central repository of the biological workflows, complemented by a set of custom and proprietary tools used to capture specific instrumental data, workflows, analyses, and nuances of each group’s unique contributions to the overall biological drug discovery process. This talk will show examples of the ecosystem of tools developed and discuss what we learned in the process.

GSK’s large-molecule research programs are based on a unique platform of antibody discovery technologies. To support and integrate the different screening, engineering and production processes, we have implemented a comprehensive R&D workflow system called the GSK’s Antibody Discovery Database (ADD). We will present how the ADD makes GSK’s lead discovery process more efficient, with use cases from GSK’s yeast and phage display as well as hybridoma and humanization processes. We will also present concrete applications showing how the ADD supports the design and engineering of novel lead candidates with improved properties, including domain antibodies (dAbs), fusion proteins, bispecifics and ADCs.

DVD-Ig proteins are dual-specific antibodies with great therapeutic potential. To scale up and automate Abbvie's DVD-Ig discovery campaigns, we have developed an informatics platform which supports the design, cloning, expression, and purification of large panels of DVD-Ig candidate molecules. This informatics platform also assesses the selectivity, cross reactivity, epitope binding, and stability. The system will enable the parallel engineering of 1,000s of DVD-Ig molecules via combinatorial design of V-domains, linker positions and lengths, and Fc chains.

GSK has a unique combination of antibody discovery technologies. We will present an overview of a comprehensive R&D data management system referred to as theGSK’s Antibody Discovery Database (ADD), a comprehensive system used to manage, share and exploit the large amount of relevant and complex information from all our Antibody discovery processes (yeast display, phage display, hybridoma/humanization) and GSKs biopharm formats, including domain antibodies (dAbs), mAbs and bi-specifics.

Building the Biomolecules Management PlatformMonica Wang, Ph.D., Lead System Engineer, Project and Program Manager, R&D Systems

Building a comprehensive Biomolecules Management Platform is a very challenging task. We are building an enterprise solution to track individual biomolecules in different drug development workflows and visualize their relationships. This platform will improve user efficiency, data quality, data exchange and collaboration for both research and preclinical development departments.

In order to address the existing and anticipated needs of Antibody engineering groups across the sites at Abbvie, we need to deploy technology based platforms covering the next gen biologics research. Here, we will focus on the successful management of an implementation and deployment project for Abbvie’s antibody lead discovery group leveraging the solution offered by Genedata Biologics.

Development and Implementation of a Biologics Data PlatformKai Herrmann, Ph.D., R&D IT Project Manager, BBS-ITS-R&D-HCR-BIO, Bayer Business Services

Biopharmaceuticals are increasingly important in the market for new medicines as they provide many advantages over small molecule-based drugs. The discovery and development of biologics molecules such as monoclonal antibodies and recombinant proteins is a complex and time-consuming exercise, and differs substantially from established small-molecule R&D processes. Hence, totally new IT and data management concepts are required. Here, we report our experience over the last 5 years of developing and implementing an innovative turn-key solution for biologics R&D data management. The goal of the new platform was to increase the number and throughput of large-molecule R&D projects, to establish a shared collaboration platform for data exchange, and to improve the quality of results. We present specific challenges encountered, such as process complexity and diversity, process changes, constant adoption to new discovery technologies, direct instrument and robotics integration, and roll-out and system adoption in a large, globally operating biopharmaceutical organization.

Biological Registration Systems at UCB and How they Integrate into the Discovery WorkflowDavid Lee, Ph.D., Principal Scientist, UCB Pharma

The benefits of informatics-driven data management systems are well known in the small molecule therapeutics arena.Extending these systems to supporting biotherapeutics presents a number of challenges. We present a novel data management system, BioQuest, integrating bespoke and best in class software systems designed to capture and integrate NBE data at UCB. We will focus on registration systems,in particular on the antibody and non-antibody protein registration system based on the Genedata BiologicsTM platform.

YBase – A New Integrated Workflow Platform for High-Throughput Antibody DiscoveryBiopharmaceuticals and specifically monoclonal antibodies play an increasingly important role in the market for new medicines. The discovery and development of biopharmaceuticals is a complex and time-consuming exercise. MorphoSys is making this more efficient and robust by standardizing and automating the underlying processes in order to scale-up R&D operations. Here, we present the development and implementation of an innovative turn-key solution called YBase which supports biopharma R&D workflow and data management, developed in collaboration with Genedata. We present the specific challenges encountered, including process complexity and new technology support. Examples cover processes from antibody library generation and screening to protein engineering, expression, purification, and analytics. YBase was built on the Genedata BiologicsTM platform, utilizing a structured and agile development approach. The resulting YBase platform is a powerful resource that enables a very significant increase in the throughput of R&D projects, setting new standards for therapeutic antibody generation in the biopharma industry.

High-throughput selection and screening of large antibody libraries need a robust data management and analysis platform able to track sequence evolution and aggregate assay data for hit and lead selection. We will present use cases to highlight the impact of incorporating appropriate bioinformatics tools and information management system on antibody generation by AbbVie’s in vitro display technologies.

Sequences and data management and analysis during the selection and screening of three ~10^9 antibody libraries during an antibody affinity maturation by yeast display. We will present a new workflow platform that enables a significant increase in throughput in the generation and testing of optimized antibody molecules. Concrete use cases illustrating examples from HT Antibody screening & engineering. Examples will cover yeast / phage / mRNA display, and other Ab discovery technologies.

We have implemented an automated HT biologics screening and an automated transient mg-scale antibody production process for the discovery, optimization and production of monoclonal antibody leads. We describe a typical workflow from Fab screening via IgG reformatting to IgG research material production with focus on data management supported by Genedata’s Biologics software solution.

Recent advances in cell line development and automation technologies enable the parallel expression of large numbers of biomolecules. We present a novel data management and workflow support system based on Genedata BiologicsTM which captures production and characterization data for both biotherapeutics and tool proteins. The system is optimized for high-throughput processes, spanning molecular biology, expression, purification, and analytics workflows. We will present use cases with emphasis on antibody expression.

UCBPresented at Pharmaceutical IT Congress, September 2012, London, UK

The number and type of biotherapeutics being developed is increasing year on year. The benefits of informatics driven data management systems are well known in the small molecule therapeutics arena. Extending these systems to supporting biotherapeutics presents a number of challenges. We present a novel data management system, BioQuest,integrating bespoke and best in class software systems designed to capture and integrate NBE data at UCB. We will focus on registration systems, in particular on the antibody and non-antibody protein registration system based on the Genedata BiologicsTM platform.

We have implemented an automated HT-biologics screening process for the discovery and optimization of monoclonal antibody leads. We will describe discovery and optimization of monoclonal antibody leads. We will describe examples of our laboratory workflows from Fab screening to lgG reformatting with focus on data management support using Genedata’s Biologics software platform.

We have implemented an enterprise-level software solution together with our partner Genedata to comprehensively support biologics R&D activities. We show how we have integrated all steps from HT biologics screening to cell line development into one workflow.

Customers

"We are very pleased with Genedata Biologics as our central biologics registration and data management platform."

Dr. Phil Scordis
Director of Informatics, UCB Pharma

"... accelerates our antibody discovery programs as we develop the next generation of biologics drugs"

“One of the reasons we chose Genedata Biologics was the platform’s process coverage. We required that the full diversity of Pfizer’s large-molecule processes and technologies be supported by one integrated system.”

Dr. Sergio Rotstein
Director of Research Business Technology, Pfizer

“We undertook a thorough selection process to find the best antibody workflow platform and Genedata Biologics was the obvious choice."

Dr. Miguel Teodoro
Head of IT Research, Boehringer Ingelheim

"Genedata Biologics is a key component of our growth plans in the immuno-oncology and next-generation ADC space."